A Dose of Reality

Tucked away among a long line of gray, pre-fab warehouses in an Arden Hills industrial park, Distribution Systems and Services does a tidy business handling packaging and shipping tasks for much larger corporations. Inside, in a room the size of an airplane hangar, sit scores of pallets filled with all kinds of merchandise. Among the pallets are hundreds of cases of Reality Female Condoms in their original retail packaging. Some of the boxes are dusty and show signs of age.

Three tables serve as a makeshift workstation for employees whose job it is to open the boxes and relabel them. One employee removes the computer-printed 1996 expiration date from the back of the individual condom packages with nail-polish remover. Another affixes a sticker bearing a new expiration date of 1999 to the packages, while a third counts the condoms and places them in shipping boxes.

For the thousands of relabeled Reality Female Condoms, DSS is just the first stop. The condoms, introduced to the U.S. market in 1993, didn't sell well. The Female Health Co., manufacturer of the Reality Female Condom, hasn't seen enough sales from its lone product to turn a profit for several years. Consequently, many of these repackaged condoms are slated for distribution to pharmacies and public health clinics throughout the world.

Retailing for $2-$3 each, the Reality Female Condom looks like a rounded plastic bag secured on each end to a slightly more rigid plastic ring. The smaller ring on the closed end anchors the device against a woman's cervix much the same way a diaphragm does. The larger ring at the open end provides another anchor plus protection for the external genitalia. The 7-inch sheath is made of polyurethane, which makes it more expensive to manufacture than latex condoms, but less likely to cause an allergic reaction in users.

After an initial flurry of excitement, the condoms languished on store shelves, perhaps because of what sex columnist Dan Savage called the "yuck factor." Studies have shown that while women like the fact that they--and not their partners--control the method, they find the female condom cumbersome and too large, and complain that it "looks like a plastic bag." Indeed, when the FDA approved the product in 1993, agency Commissioner David Kessler admitted that Reality wasn't all he would have wished for, but was better than nothing at all.

The thousands upon thousands of stickers being applied to Female Health's resurrected surplus of Reality Female Condoms illustrate not only the difficulty and expense of bringing new forms of birth control to market, but also the struggle that must be fought by those same manufacturers to get the buying public's attention. The story is one of a well-intentioned idea--to give women a way to control their exposure to HIV and STDs--that didn't catch on.

Five years after its introduction, the female condom appears finally to have found its market: Straight women in the United States may not see Reality as a godsend, but women in AIDS-plagued Third World countries do, along with a growing number of gay men.

It was a Danish physician, Lasse Hessel, who invented the female condom in 1988. Hessel then sold manufacturing rights to the condom to a London company which, with the help of a Danish nonprofit, developed a production process and won permission to market the device in a number of countries, not including the United States. The first batch was sold in Switzerland in 1992.

Hessel sold the rights to make and sell the condom in the United States, Canada, and Mexico to Wisconsin Pharmacal Co., Inc. of Jackson, Wisconsin. The company, which previously had manufactured chemical products such as home cleaners and institutional health-care products, undertook the studies necessary for FDA approval. The device hit store shelves in the United States in 1994. Headlines touted Reality as the solution to women's need for a product they controlled that would offer protection from AIDS and other sexually transmitted diseases. Wisconsin Pharmacal decided to concentrate all of its efforts on marketing the condoms, so it sold off the consumer-chemical portion of its business, and, changing its name to the Female Health Co., moved its headquarters to Chicago. Female Health was so confident its product would catch on that it even bought the London company that earlier had developed the manufacturing process.

Sales, however, failed to take off. Studies would later show that few women were even willing to try the new method. Melissa Perry of the Medical College of Wisconsin's Center for AIDS Intervention Research gave women who lived in low-income housing developments in five U.S. cities free condoms and showed them how to use them. When the study began, 14 of the 200 women surveyed said they'd tried Reality. Two months later, only 25 women had tried the method.

Dr. Mary Ann Leeper, president of Female Health, concedes that she's disappointed American women haven't been quicker to accept the female condom. "But talking about [disease] prevention in the United States isn't an easy sell and sex is ever harder to discuss," says Leeper.

But while American women puzzled over what to make of the new birth-control method, its maker lost money. According to documents filed last month with the federal Securities and Exchange Commission, Female Health lost $5.6 million for the year ended September 30, 1997, bringing the company's cumulative deficit to $36.2 million. Total assets for the company equal just $4.9 million. The American Stock Exchange notified Female Health that because of its financial status, administrators were considering dropping it from the exchange.

Female Health needed cash, which meant unloading its backlog of unsold condoms. In 1996, the Joint United Nations Programme on HIV/AIDS signed a three-year agreement with Female Health to distribute the female condom in developing countries in exchange for a discount on the product. (The company is selling the condoms to health agencies in both the Third World and industrialized nations for less than $1 each.)

Which is where Arden Hills' DSS came into the picture. DSS was already shipping orders for Female Health. Last spring, Female Health asked it to begin shipping unsold condoms to public health agencies for use in such impoverished countries as Uganda, Paraguay, Ghana, Haiti, and Indonesia. First, however, the expiration dates needed changing.

Which isn't as shady as it sounds. In what Dan Schultz of the FDA calls a "common strategy," companies seeking approval from the agency often propose a shorter life span than is actually the case. Because the testing process products must go through to gain FDA approval is costly, companies can ask for the life span that they have hard data to support. Then once the product is on the market they have the time and the capital coming in to do the long-term testing needed to earn an extended and more realistic shelf life.

Reality was initially given a three-year shelf life, Schultz explains. Later testing done by Female Health determined that the condoms could last for at least five years, so last March, the FDA approved Female Health's request for a new expiration date and DSS began repackaging the long-stored excess inventory.

There's little question the relabeled condoms are safe to use, according to members of the medical community. "The expiration date is much less important for the female polyurethane condom than the latex condom," explains Dr. Robert Hatcher, author of the textbook Contraceptive Technology. "Latex condoms are much more fragile. Polyurethane is also not as heat or moisture sensitive as latex and doesn't require special storage. The female condom could last much longer than five years."

The FDA's decision, coupled with contracts to sell Reality to public health agencies throughout the United States and elsewhere, meant Female Health could sell off its backlog. During the first quarter of 1998, the sales boost increased revenue for Female Health by 116 percent.

Leeper says Reality stands a good chance of gaining popularity in other countries. "In some countries women recognize they are more at risk for STDs and HIV," Leeper says. Studies show that women who perceive themselves at high risk for infection with HIV or STDs are more likely to use Reality, and more than 90 percent of all adults with HIV or AIDS live in developing countries. Women in the United States perceive these infections as less of a threat, says Leeper. "There's a lot of denial and a sense of invulnerability in the United States."

Researchers at the World Health Organization say that while studies in developing nations turn up the same "yuck factor," women there, as Leeper predicted, are actually trying and using the female condom.

The other group in which Reality seems to be gaining ground is gay men. Two weeks ago, Jeffrey Gould received his second shipment of condoms from DSS. A health educator with Washington state's nonprofit Thurston County Public Health Co., Gould manages a program that distributes the condoms to gay men for free.

After hearing that gay men in London used Reality, several months ago Gould bought a box of the devices and handed them out in a couple of support groups for gay men to rave reviews. "What I've heard from women is that they're a bit noisy and that they looked big and bulky. Many women just looked at it and said, 'Ooh that looks scary,'" he says. But "men are loving them. They love the increased freedom. I've had lots of positive feedback."

Since then, Gould has heard that public health programs in other states have had similar success distributing the female condom to gay men. Tom Lindsay, manager of the Minnesota AIDS Project's community outreach program, worked on a study conducted by San Francisco public health agencies that examined Reality's potential for use by gay men. He says MAP has not begun distributing the female condoms for free because they're very expensive.

Leeper says that while Female Health doesn't market the condom directly to gay men, she knows there are pockets of men who are using them. "Information travels among gay men about it," she says. "We know that clusters of men are using it." Female Health did do one study which it says shows that the female condom is potentially strong enough for use during anal sex. The company developed instructions for its use, which Leeper says are under consideration by the FDA. If the agency eventually decides that anal sex is an approved use for the condoms, Female Health will begin marketing to gay men.

The bottom line, says Leeper, is that it takes enormous amounts of both time and money to launch a new form of birth control. Once on the market, the education process is long and expensive, and until something better can be developed, the Reality Female Condom is what we've got. "I think if a nonhormonal method could be found that killed both bacteria and viruses and that was invisible, it would be extremely successful," Leeper says. "But the trouble is it's difficult to find. Many have been working on it for years and still haven't come up with it yet."

Which means that for now the workers at DSS will continue repacking the "more than thousands" of Reality Female Condoms that Leeper says are entitled to an extended expiration date.